CN1976731A - 流体输送装置 - Google Patents

流体输送装置 Download PDF

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CN1976731A
CN1976731A CNA2005800140364A CN200580014036A CN1976731A CN 1976731 A CN1976731 A CN 1976731A CN A2005800140364 A CNA2005800140364 A CN A2005800140364A CN 200580014036 A CN200580014036 A CN 200580014036A CN 1976731 A CN1976731 A CN 1976731A
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fluid
inner chamber
intubate
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D·W·希金博特姆
J·R·普雷斯科特
M·A·齐卡
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Novartis AG
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    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1454—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons spring-actuated, e.g. by a clockwork
    • A—HUMAN NECESSITIES
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
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    • A61M2005/3115—Filling or refilling spring-assisted
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft

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Abstract

一种注射器状的装置，具有加压活塞在其中往复移动的内腔。所述内腔在一端与装有待输送给眼睛的药物的药瓶相连，并在另一端与用于对眼睛给药的针管或插管相连。将所述活塞近端向后拉，会在所述内腔中产生真空并将药物抽出药瓶。一旦释放所述活塞，一弹簧向前推动活塞，对所述内腔加压并迫使药物流出所述插管。一单向阀防止药物回流到药瓶中。处于所述内腔与插管之间的一夹紧阀允许药物停止从所述插管流出。通过改变所述内腔、活塞和弹簧的尺寸，药物流出所述插管的流率可得以控制。

Description

流体输送装置
技术领域
本发明总的涉及向眼睛后部输送适用于眼病的药物活性剂，更具体地，涉及一种向黄斑附近的人眼后段输送药团的眼球筋膜下(sub-Tenon)输送装置。
背景技术
眼后段的一些疾病和疾患会危及视力。老年黄斑变性(ARMD)、脉络膜新血管化(CNV)、视网膜病(譬如，糖尿病致视网膜病、玻璃体视网膜病变)、视网膜炎(譬如，细胞巨化病毒(CMV)视网膜炎)、葡萄膜炎、黄斑水肿以及青光眼均为一些例子。
老年黄斑变性(ARMD)是老年人失明的主要原因。ARMD会侵袭视力中心并使其模糊，导致难于或者无法进行阅读、驾驶以及其他精细工作。仅在美国，每年就会出现200,000个新的ARMD病例。现行估计，大约40％的75岁以上人群和大约20％的60岁以上人群，均发生了某种程度的黄斑退化现象。“湿型”ARMD是极易导致失明的ARMD类型。在湿型ARMD中，新生成的脉络膜血管(脉络膜新血管化(CNV))会发生漏液现象，并且逐渐对视网膜造成损伤。
对于ARMD中的特定病例CNV，目前发展有两种主要的治疗方法：(a)激光凝固治疗和(b)使用血管形成抑制剂。但是，激光凝固治疗可能会对视网膜造成伤害并且当CNV靠近中央凹(fovea)时不实用。而且，随着时间的推移，激光凝固治疗常常会造成复发CNV。抗血管生成化合物的口服也正在被试验以作为ARMD的***治疗。然而，由于药物特定的代谢限制，***投药通常给眼睛提供低于治疗水平的药量。因此，为了获得有效的眼内药浓度，要么需要使用无法接受的高剂量，要么需要重复多次使用常规剂量。已经发展出各种用于向眼睛局部输送抗血管形成化合物的植入器。这类植入器的例子在授权给Wong的美国专利No.5,824,072、授权给Gwon等的美国专利No.5,476,511以及授权给Ashton等的美国专利No.5,773,019中予以了披露。
此外，已经公知使用一种直的、5/8英寸长的计量针来执行皮质激素的眼球筋膜下注射(sub-Tenon injection)用于治疗与葡萄膜炎或眼体前部手术相关的后期葡萄膜炎或黄斑水肿。在此类方法中，医生试图将针尖放在黄斑附近但并不穿透后部的睫状体动脉或视神经。但是，因为医生不能看到针尖，也不能看到眼眶内眼球由于与直形针相接触而发生的运动，这样难于将针尖精确地放置在黄斑附近的期望位置上。出于同样的原因，也难于确定针尖是否被正确地放置在眼球筋膜囊之下。上述方法不能确保将特定量的药物始终如一地输送给黄斑上的区域。事实上，资料指出使用该方法仅有57％左右的注射药物被置入到覆盖在黄斑区域上的眼球筋膜下空间。此外，沿着巩膜的曲面移动直形针会导致眼球筋膜囊上的“***”或延展。这种活动可能导致穿透眼球筋膜囊，从而使得药物被注射到周围组织中去。另外，这种活动还可能导致无意中穿透巩膜，从而使得药物注射到玻璃质腔中去。更为重要的是，穿透巩膜可能导致对眼睛的严重伤害甚至失明。这类穿透已经记录的并发症包括眼眶出血、中心视网膜静脉阻塞和中心视网膜动脉堵塞。
与向黄斑附近的人眼后段眼球筋膜下输送药团的另外一个考虑在于，药物必须缓慢给药并处于相对较低的压力下，以便保留在组织中而不是通过针管通道泄漏出组织。
因此，在眼病领域中，需要一种改进的装置，用于向黄斑附近的人眼后段进行眼球筋膜下输送药团。
发明内容
本发明通过提供一种注射器状的装置，从而对现有技术进行改进，该装置具有加压活塞在其中往复移动的内腔。所述内腔在一端与装有待输送给眼睛的药物的药瓶相连，并在另一端与用于对眼睛给药的针管或插管相连。将所述活塞近端向后拉，会在所述内腔中产生真空并将药物抽出药瓶。一旦释放所述活塞，一弹簧向前推动活塞，对所述内腔加压并迫使药物流出所述插管。一单向阀防止药物回流到药瓶中。处于所述内腔与插管之间的一夹紧阀(pinch valve)允许药物停止从所述插管流出。通过改变所述内腔、活塞和弹簧的尺寸，药物流出所述插管的流率可得以控制。
相应地，本发明的一个目的在于提供一种注射器状的装置，该装置具有加压活塞在其中往复移动的内腔。
本发明的另一个目的在于提供一种装置，该装置用于药团向黄斑附近的人眼后段的眼球筋膜下输送。
本发明的又一个目的在于提供一种药物输送装置，其中被输送药物的流率可得以控制。
通过以下详细的说明书及附属权利要求，本发明的这些和其他优点和目的将变得明显。
附图说明
图1是本发明的药物输送装置的放大示意图。
图2是本发明的药物输送装置的分解示意图。
图3是本发明的药物输送装置的放大横截面视图。
具体实施方式
如图1-3中最佳显示地，本发明的药物输送装置10大体包括本体12、圆筒体14、头锥或尖端16以及插管18。本体12大体是中空的，它的近端(proximal end)20大体是敞开的且其尺寸适于容纳装有待输送药物的密封药瓶54。圆筒体14大体也是中空的并具有内腔22。头锥或尖端16与本体12相对置地装配于圆筒体14并保持插管18。插管18可以是任何合适的插管，譬如美国专利No.6,413,245B1(Yaacobi等)中所描述的插管。活塞24的尺寸通常适于在内腔22内紧贴地往复移动，但包括具有多个拨片28、其尺寸适于在本体12内往复移动的凸缘26。拨片28装配在本体12的狭槽30中，并且当活塞24安装于装置10中时允许握住拨片28。凸缘26使活塞24衔接弹簧32，该弹簧32被安装在本体12中处于活塞24与近端20之间。拉动拨片28迫使活塞24压缩弹簧32。同轴安装在弹簧32内的是阀套34。阀套34将阀36、阀盖38和刺管40定位且保持在本体12中。从阀36到内腔22的远端(distal end)、纵向延伸通过阀套34和活塞24的是管道42。如同以下将要描述地，管道42使得流体可以从药瓶(未显示)流经刺管40、阀盖38和阀36并进入内腔22。连接于圆筒体14的远端、并与内腔22流体连通的是释放管44。释放管44通过释放钮46和插管连接器48与插管18相连通。释放钮46正常情况下夹紧闭合释放管44并被弹簧50保持在其位置上。
在使用时，装有待输送药物的密封药瓶54被放在本体12敞开的近端20附近使得刺管40刺入药瓶54。在运输期间，可以通过防护罩58上的夹具56，该夹具被***到本体12的狭槽52中，将药瓶54适当保持在本体12中而不被刺穿。通过握住并拉动拨片28，将活塞24抵住弹簧32向后拉。随着活塞24被拉出内腔22，内腔22中产生了真空。该产生的真空将药物抽出药瓶54并流经管道42、阀36、阀盖38和刺管40。一旦药物从药瓶54抽出并进入内腔22，活塞24可以被释放，但活塞并不能向前移动，因为内腔22中现在充有流体而且释放钮46防止任何流体通过释放管46离开内腔22。此外，阀36防止任何流体回流到药瓶54中。如果将释放钮46抵着弹簧50按压，释放管44被松开，从而允许流体流出内腔22并通过插管18。弹簧32抵住活塞24的力对内腔22施压，由此有助于将流体快速排出插管18。
本领域的技术人员将会认识到，通过改变内腔22、活塞24和释放管44的尺寸，并更换弹簧32，可以获得特定的流体压力和流率。
本说明书被指定用于例证和说明的目的。对于相关领域的技术人员显然可知，在不偏离其范围或精髓的情况下，可以对上述发明作出改变和修改。

Claims (7)

1.一种流体输送装置，包括：
a)大体中空的敞开的本体，其尺寸和形状适于接纳装有待输送流体的瓶；
b)包含与所述本体的远端相连的内腔的圆筒体；
c)与所述圆筒体的远端相连并与所述本体相对置的头锥，该头锥保持插管；
d)弹簧加载的活塞，该活塞在所述内腔和本体内往复移动；以及
e)延伸通过所述本体、圆筒体和头锥的流体通路，该通路用于提供从所述流体瓶到所述插管的流体连通。
2.如权利要求1所述的流体输送装置，其中所述流体通路包括包含在所述本体内、用于刺穿所述流体瓶的刺管。
3.如权利要求1所述的流体输送装置，其中所述流体通路包括允许流体流出所述流体瓶并防止流体进入所述流体瓶的阀。
4.如权利要求1所述的流体输送装置，其中所述流体通路包括用于允许流体从所述内腔流至所述插管的释放管。
5.如权利要求4所述的流体输送装置，其中所述流体通路包括用于防止流体在所述释放管中流动的释放管。
6.一种流体输送装置，包括：
a)大体为中空的敞开的本体，其尺寸和形状适于接纳装有待输送流体的瓶；
b)包含与所述本体的远端相连的内腔的圆筒体；
c)与所述圆筒体的远端相连并与所述本体相对置的头锥，该头锥保持插管；
d)弹簧加载的活塞，该活塞在所述内腔和本体内往复移动；以及
e)延伸通过所述本体、圆筒体和头锥并用于提供从所述流体瓶到所述插管的流体连通的流体通路，该流体通路包括用于刺穿所述药瓶的刺管以及用于提供所述内腔与插管之间流体连通的释放管。
7.如权利要求6所述的流体输送装置，其中所述流体通路包括用于防止流体在所述释放管中流动的释放管。
CNA2005800140364A 2004-08-30 2005-08-16 流体输送装置 Pending CN1976731A (zh)

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US10/929,189 US20060047250A1 (en) 2004-08-30 2004-08-30 Fluid delivery device
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EP (1) EP1784234A4 (zh)
CN (1) CN1976731A (zh)
AU (1) AU2005280385A1 (zh)
BR (1) BRPI0514797A (zh)
CA (1) CA2563088A1 (zh)
WO (1) WO2006026154A2 (zh)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103328111A (zh) * 2011-02-01 2013-09-25 博士伦公司 符合人体工程学的手操作性流体分配装置
CN103919642A (zh) * 2014-03-14 2014-07-16 中国人民解放军第三军医大学第一附属医院 巩膜后注射***

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WO2006026154A2 (en) 2006-03-09
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AU2005280385A1 (en) 2006-03-09
CA2563088A1 (en) 2006-03-09

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